The Characterization of Small Bowel and Colonic Involvement in Patients With Seronegative Spondyloarthritides (SPONDILENDO)
|ClinicalTrials.gov Identifier: NCT00768950|
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : August 14, 2013
Up to 60% of patients with Seronegative Spondyloarthritides have inflammation in the colon or ileum. This is usually asymptomatic, but in 5 to 10% of patients with SA, Frank IBD will develop. Lesions of the bowel could also be present in the SA patients because of the potential injury posed by the NSAIDS, a common used medication in this setting.
It is the bowel involvement in patients with SA that we propose to characterize, partly because there are scant communicated data in the medical literature, especially regarding small bowel lesions.
|Condition or disease||Intervention/treatment|
|Spondyloarthropathies||Procedure: Capsule endoscopy examination Procedure: Colonoscopy|
The Seronegative Spondyloarthritides (SA) are a group of disorders that share certain clinical features and an association with the hla-b27 allele, having also overlapping features with inflammatory bowel disease (IBD).
Up to 60% of patients have inflammation in the colon or ileum. This is usually asymptomatic, but in 5 to 10% of patients with SA, Frank IBD will develop.
Lesions of the bowel could also be present in the SA patients because of the potential injury posed by the NSAIDS, a common used medication in this setting.
On the other hand, biologics used to treat patients with SA are believed to favorably influence the small bowel lesions that are concomitantly present.
It is the bowel involvement in patients with SA that we propose to characterize, partly because there are scant communicated data in the medical literature.
The design of the proposed study involves performing one full colonoscopic examination (including ileoscopy) followed by one capsule endoscopy examination to the patients with SA. Prior to these examination, the patency of the gi tract will be tested using a patency capsule. If the patency of the gi tract is not confirmed, then the capsule endoscopy examination is abandoned.
Our aim is to explore about 100 patients in three years, thus having a close-to-reality "look" into the presence and extent of bowel involvement in the pool of the patients having SA; and also to characterize the lesions mainly depending on the treatment received, concomitant pathology and the form of the disease. We also aim to identify a relationship between the lesions found at colonoscopy and capsule endoscopy, the purpose being the possibility to predict one having only performed the other.
Thus, we hope to identify the therapeutic strategies that are most suited in the management of these patients.
|Study Type :||Observational|
|Actual Enrollment :||65 participants|
|Official Title:||The Characterization of Small Bowel and Colonic Involvement in Patients With Seronegative Spondyloarthritides|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Patients with spondyloarthropathies (ankylosing spondylitis, reactive arthritis, psoriatic arthritis and spondylitis, enteropathic arthritis and spondylitis, juvenile-onset spondyloarthritis, and undifferentiated spondyloarthritis) as defined by the AMOR criteria
Procedure: Capsule endoscopy examination
Examination of the small bowel with endoscopic videocapsule
Other Name: Given imaging capsule SB2Procedure: Colonoscopy
Endoscopic examination of the large bowel and terminal ileum
Other Name: Olympus Evis Exera II videocolonoscope
- Number of patients with bowel lesions [ Time Frame: July 2012 ]
- Correlation of the bowel lesions with patient status [ Time Frame: July 2012 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768950
|Gastroenterology Department, Colentina Clinical Hospital|
|Bucharest, Romania, 020125|
|Principal Investigator:||Mihail R Voiosu, M.D., Ph.D.||Carol Davila University of Medicine and Pharmacy|
|Study Chair:||Mihai Rimbas, M.D.||Carol Davila University of Medicine and Pharmacy|